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This study is designed to compare three different techniques in ablation of paroxysmal atrial fibrillation. Namely, the Medtronic multi-electrode phased radiofrequency ablation system, the Biosense Webster irrigated multi-electrode phased radiofrequency ablation system, and minimally invasive thoracoscopic surgical ablation. The study hypothesis is that surgical and Biosense Webster ablation are non-inferior to Medtronic ablation.
A target of 75 participants will be randomised 1:1:1 to one of the three treatment arms. Each participant will have an implantable loop recorder (ILR) prior to ablation in order to assess AF burden. After ablation, each participant will be followed up for a year. The ILR will be used to assess reduction in AF burden.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biosense Webster ablation | Active Comparator | Biosense Webster irrigated multi-electrode phased radiofrequency AF ablation |
|
| Surgical ablation | Active Comparator | Minimally invasive thoracoscopic surgical AF ablation |
|
| Medtronic ablation | Active Comparator | Medtronic multi-electrode phased radiofrequency AF ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ILR insertion | Device | Insertion of implantable loop recorder |
|
| Measure | Description | Time Frame |
|---|---|---|
| AF burden | Total proportion of time spent in AF as assessed by ILR | 12 months after ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Time to AF recurrence | Time to recurrence of any AF after ablation | Up to one year |
| Time to first symptomatic AF recurrence | Time to first symptomatic AF recurrence as assessed by ILR. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Sulke, MD | Eastbourne General Hospital | Principal Investigator |
| Stephen S Furniss, MD | Eastbourne General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastbourne General Hospital | Eastbourne | E Sussex | BN21 2UD | United Kingdom | ||
| Royal Sussex County Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29092038 | Derived | Sugihara C, Furniss S, Hyde J, Lewis M, Sulke N. Results of the first investigator-initiated randomized clinical trial of nMARQTM, PVACTM, and thoracoscopic ablation for paroxysmal atrial fibrillation. Europace. 2018 Nov 1;20(FI_3):f384-f391. doi: 10.1093/europace/eux267. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| AF ablation | Procedure | AF ablation |
|
| Up to one year |
| Change in QoL measures | Change in Quality of Life measures assessed by questionnaire. | 12 months after ablation |
| Brighton |
| Sussex |
| BN2 5BE |
| United Kingdom |
| D013568 |
| Pathological Conditions, Signs and Symptoms |